Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017461134

FEI Number

3017461134

Entity Name

VIEN PHAT IMPORT EXPORT SERVICE TRADING JOINT STOCK COMPANY

City/State/Country

Ben Thanh Ward Ho Chi Minh, VN

Establishment Address

63B Calmette, Ben Thanh Ward Ho Chi Minh 70000, VN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

VIEN PHAT IMPORT EXPORT SERVICE TRADING JOINT STOCK COMPANY (Owner Number: 10092367)

Owner / Operator Contact Address

63B Calmette, Ben Thanh Ward, VN-SG 70000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound care product Sarafit Cotton non-woven gauze Sterile Scope WiperX Surgical gauze - TroxII Type A,B,C Sterile PatesponX RS-L Marker BASIC GOWN WITH MASK BASIC GOWN REINFORCED (S,M,L,XL) HIGH STANDARD GOWN (S,M,L,XL) Procedure pack - ENT PACK ENT PACK WITH INCISE DRAPE ENT PACK WITH TAPE Microscope drape Ureteroscopy drape Urology pack BASIC GOWN CHEST REINFORCED WITH MASK Surgical gown - BASIC GOWN CHEST REINFORCED (S,M,L,XL) RIGHT OPHTHALMIC DRAPE LEFT OPHTHALMIC DRAPE Surgical drape - OPHTHALMIC DRAPE BASIC GOWN CHEST REINFORCED WITH MASK Surgical gown - BASIC GOWN CHEST REINFORCED (S,M,L,XL) HIGH STANDARD GOWN (S,M,L,XL) SURGICAL GOWN (S,M,L,XL) Eye pads Bed sheet Plastic forceps - White forceps Adhesive drape OP-Tape Incision film CARDIOVASCULAR PACK CESAREAN PACK FEMORAL ANGIOGRAPHY PACK Scalpel ACIST Kodama® Intravascular Ultrasound Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-21
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-12-29
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2025-12-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-12-29
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2024-12-29
HMW	Drape, Microscope, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2025-12-21
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2025-12-21
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-12-29
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2024-12-29
FME	Gown, Examination	General Hospital	Class 1	880.6265	2024-12-29
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-12-29
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-12-21
QTV	Mattress And Bed Deck Cover (Medical Purposes)	General Hospital	Class 1	880.6190	2025-12-21
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-12-29
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2025-12-21
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-12-29
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-12-21
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-06-15

Official Correspondent

YOSHIKAZU NODA

US Agent Details

Curtis Dalrymple Email: manager.ucc.us@gmail.com Phone: (360) 7398022

Related Public Records

Same Entity

VIEN PHAT IMPORT EXPORT SERVICE TRADING JOINT STOCK COMPANY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23
K251231	ABBOTT MEDICAL	ViewFlex X ICE Catheter, Sensor Enabled	2025-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017461134. Last updated year: 2026. Please use registration number 3017461134 when referencing this establishment in official correspondence.